MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGE II IMMUNOASSAY; RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)

Model Number IGE

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received a questionable high elecsys ige ii immunoassay result for one patient sample from modular e module serial number (b)(4).The initial result was 46888 iu/ml (>2500 undiluted) and was reported outside of the laboratory.The results for subsequent electrophoresis testing did not agree with this result as no increased immunoglobulin pattern was visible.Therefore, the sample was sent to another laboratory for confirmation.The result by a siemens method was 1002 iu/ml.The customer repeated an aliquot of the same sample on the modular e module and the results were >2500 undiluted and >50000 with an automatic dilution.There was no allegation of an adverse event.From analysis of the calibration and quality control data, a general reagent issue could be excluded.As no sample material was available, the investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS IGE II IMMUNOASSAY
• Type of Device: RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7586490
• MDR Text Key: 110708343
• Report Number: 1823260-2018-01829
• Device Sequence Number: 1
• Product Code: JHR
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K061970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: IGE
• Device Catalogue Number: 04827031190
• Device Lot Number: 26628902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1